Acquisitions /mergers/joint-ventures

January 2, 2015

Cardio3 buys OnCyte oncology unit

Celdara Medical (USA) agreed to sell its oncology unit OnCyte to Cardio3 Biosciences (Belgium) for $182 million. The OnCyte pipeline includes three autologous Chimeric Antigen Receptor (CAR) T cell treatments and an allogenic T cell technology.

January 5, 2015

NPS Pharma is up for sale

New Jersey based NPS Pharmaceuticals is officially seeking for a buyer. The Wall Street Journal reports that Goldman Sachs has started to contact companies to evaluate their interest in NPS, which is currently valued at $4.5 billion.

Business

January 5, 2015

Janssen's in $835 deal in antisense drug pact with Isis

Janssen Biotech and Isis Pharmaceuticals agreed to collaborate in the discovery and development of antisense drugs for gastrointestinal autoimmune disorders using ISIS’s RNA-targeted platform. The deal includes three development programs and grants Janssen the option to license a drug from each program. Under the agreement Isis will receive $35 million in upfront payments and almost $800 million in milestone payments and license fees plus sales royalties.

January 5, 2015

Amgen and Kite Pharma enter a cancer immunotherapy agreement

Kite Pharma and Amgen enter a strategic alliance to jointly develop and market "next generation" chimeric antigen receptor (CAR) T cell immunotherapies using the Kite’s engineered cell therapy technology. Under the agreement Kite is to provide research and development/manufacturing capabilities and expertise, and will carry out all preclinical research and cell manufacturing/processing. The deal entitles Kite to $60 million upfront, R&D funding and $525 million per Amgen development program plus sales royalties. Amgen will receive $525 million for each Kite program plus sales royalties.

January 6, 2015

Gilead buys Phenex liver drugs in $470 million deal

Gilead Sciences has agreed to acquire liver disease drugs from German biotech Phenex Pharmaceuticals. Gilead will pay an undisclosed upfront fee plus additional payments which may potentially be worth up to $470 million. The drugs are farnesoid X receptor (FXR) agonists for diseases including non-alcoholic steatohepatitis (NASH). NASH is a common, serious chronic disease, characterised by inflammation and excessive fat accumulation in the liver, which may lead to progressive fibrosis, cirrhosis and liver failure.There are currently no approved therapies. Genfit’s (France) GFT 505 is the current lead in the emerging NASH field.

January 7, 2015

Novartis moves into genome editing through two collaboration deals

Novartis enters a license and collaboration agreement with Intellia Therapeutics for the discovery and development of new drugs utilizing Clustered regularly interspaced short palindromic repeats (CRISPR) genome editing technology and Caribou Biosciences for the development of drug discovery tools.

Under the terms of the agreement with Intellia, Novartis receives exclusive rights to develop all collaboration programs focused on engineered CARTs and the right to develop an undisclosed number of targets In return, Novartis is increasing its equity investment in Intellia, is making an upfront payment and will provide technology access fees and funding for R&D programs during the five-year term of the collaboration,

Under the terms of the agreement with Caribou, Novartis receives non-exclusive rights to Caribou's CRISPR platform for research conducted during the collaboration and will fund the one-year research program. Novartis will make an equity investment in Caribou.

Approval of drugs

January 9, 2015

Daiichi Sankyo's novel oral anticoagulant drug, Savaysa gets FDA approval

The US FDA has approved the use of Daiichi Sankyo's (Japan) Savaysa, (edoxaban) a novel oral anticoagulant to reduce the risks of stroke risk in patients with atrial fibrillation that is not caused by heart valve problems. Edoxaban, an anticoagulant drug that inhibits factor Xa, has also been approved for use in patients with deep vein thrombosis and pulmonary. Daiichi Sankyo’ s drug will compete with already-approved factor Xa inhibitors such as Bayer/Johnson & Johnson’s Xarelto (rivaroxaban), Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban) and Boehringer Ingelheim's Pradaxa (dabigatran).

FDA approves Roche’s blood screening test to detect HIV, HCV and HBV

The US FDA has approved a triple test from Roche to simultaneously detect HIV, hepatitis C and hepatitis B in donated blood and blood products. It's the first test approved by the agency to simultaneously for all three of these blood borne diseases and is expected to reduce the necessary sample volume and the testing turnaround time.

Drugs at clinical stage

January 8, 2015

Sanofi-Regeneron cholesterol-lowering drug successful in clinical trials

Sanofi and Regeneron Pharmaceuticals announce that two Phase 3 clinical trials evaluating alirocumab, dosed once every four weeks for the treatment of hypercholesterolemia, met their primary efficacy endpoints. Alirocumab is a monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9).

Ebola

Roche wins FDA approval for emergency use of rapid Ebola test

The Swiss company got a regulatory greenlight for its LightMix Ebola Zaire test, a diagnostic tool that can process as many as 96 results in just over three hours. Roche's LightMix diagnostic product is CE marked, but had not yet been approved by the FDA. Roche is not the only med tech company developing quick Ebola diagnostics. Cepheid (USA), Corgenix (USA) and bioMérieux (France) are moving ahead with their own products.

Author : Jean-Claude MULLER, Special Advisor, Innovation & International Relationship (I&IR)

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